Skip to end of metadata
Go to start of metadata

You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 11 Next »

A good data definition provides a complete description of ALL the characteristics associated with a variable.  We love your variables and what we need to fully appreciate their goodness is good old "TLV" from you.

 Stands For..More...

T

Type of Variable The most common types are dates, number, coded variables (e.g., 0 = No, 1 = Yes;  Tell us if more than one option can be selected).

L

Layout and Logic Indicate the look and feel of the variable, and when it should be displayed (e.g., only show if subject is a male).

V

Validation Indicate the rules that govern the acceptable variable values (acceptable range, units)

Keep It Simple!!

The standard look and feel a is one row per variable layout which is standard practice and always used if possible (more examples).

 

Mark It UP!!

You love your variables as much as we do, so give each variable some good old TLV and Mark It Up before sending to us!

Example Marked Up Form

Variable Standards and Defaults

 

Attribute

What’s Needed

Our Default

Variable Name

Descriptive Name

 

 

Unique code (no spaces/special characters [underscore ok])

 

Variable Type

Numeric – What is the range (min / max)?  Units?

 

No range, no unit

 

Calculation - How calculated? What if missing some values?

 

All values required for a calculation

 

Text - How many characters needed?

Unlimited for things questions like Describe, Comments

 

 

Date – What is acceptable range?

Any valid date can be entered

 

Document – How many files and how large?

 

 

Coded list (e.g., 0 = Male…)

· What are the values and labels for all options?

- do you want values displayed for data entry?

· Can more than one option be selected?

 

0=No, 1=Yes

Other lists would start with 0 and increment by 1

Values are not displayed

Only one option can be selected

Definition

Export – Can values be exported in dataset?

Exportable

 

Missing Values – Will values be assigned as “Missing” (e.g., Missing = -9)?

 

No missing value definition set up if not specified

Required

Must a value be entered?

Yes

 

Form (CRF/Questionnaire/Measure) Information

 

Attribute

What’s Needed

History

Is the form (or similar form) in another StudyTRAX project?

Formatting and Layout

Will subjects enter the data?  (i.e, need multi-device format)

 

Does the format / layout matter? (easiest/simplest electronic user-experience)

 

Describe any special formatting

Skip Patterns

When is the variable/form either shown / hidden?

 

 

Example: Skip Pattern logic

 

Form

Skip logic / condition

Pregnancy Test

Hide form for males

Demographic Data

Show text box if ‘other’ is selected for Race

 

Example: Data Collection Forms Schedule

 

Time

-10d

Day 0

Day 7

Month 3

 Month 6

Protocol Deviation

Adverse Event

Windows

±10dys

 

±1day

±2wks

±1mth

N/A

N/A

Visit

Screening

Baseline

Visit 1

Visit 2

Visit 3

*Protocol Deviation

*AE

Visit Overview

X

X

X

X

X

 

 

Study Eligibility

X

 

 

 

 

 

 

Physical Exam

X

X

X

X

X

 

X

Demographic Data

X

 

 

 

 

 

 

Complete Blood Count (CBC)

X

 

X

X

X

 

 

Electrocardiogram (ECG)

X

X

 

 

X

 

 

Pregnancy Test

X

X

 

 

X

 

 

Tuberculosis Test

X

 

 

 

 

 

 

Vital Signs

X

X

X

X

X

 

X

Adverse Event (AE) form

 

 

 

 

 

 

X

Protocol Deviation

 

 

 

 

 

X

 

 X = forms required to be filled out for visit

*Event created and forms completed as needed 

  • No labels